NAFLD clinical trial activity catching up in China, mostly driven by MNCs: GlobalData

New Delhi: China is expected to record the highest diagnosed prevalence of non-alcoholic fatty liver disease (NAFLD) in 2029, representing 44% of cases within the 16 major pharmaceutical markets (16MM). As a result, the number of clinical trials conducted in the country for this indication is gradually increasing, driven mostly by international pharmaceutical companies, but lacks substantial participation from domestic firms, says GlobalData, a leading data and analytics company.

GlobalData’s Epidemiology and Market Size Database reveals that the number of the total diagnosed prevalent cases of NAFLD in China is expected to grow at an annual growth rate (AGR) of 2.04% from nearly 273 million cases in 2022 to 303 million cases in 2029. The number of total prevalent cases of NAFLD in the country is expected to be over 506 million in 2022.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “NAFLD is part of the metabolic syndrome spectrum and is linked to diabetes and impaired lipid levels. The disease in itself may not be life threatening, but its prognosis includes more complicated liver conditions like non-alcoholic steatohepatitis (NASH), cirrhosis, and cancer. Metabolic diseases, though largely preventable, are often neglected in initial stages due to lack of diagnosis, patient awareness and early treatment options. This has led to higher diagnosed prevalence rates of the disease.”

According to GlobalData’s Pharma Intelligence Center, China has the highest number of clinical trials that were initiated in NAFLD in the APAC region over the past decade. However, most of these clinical trials were sponsored either by non-commercial Chinese sponsors, like institutions or investigators, or by international commercial sponsors. Moreover, almost all clinical trials for drugs in mid-to-late-stage development in NAFLD were sponsored by medium and large sized international companies. GeneScience Pharmaceuticals, Gannex Pharma (a wholly owned company of Ascletis Pharma) and PegBio are the only Chinese companies currently known to have been active in early-to-mid stage clinical trials for drugs in NAFLD.

However, there are currently 10 pre-clinical assets in NAFLD from major domestic companies in China, including publicly listed companies such as Innovent Biologics, Sihuan Pharmaceutical Holdings and Shenzhen Chipscreen Biosciences, as well as private companies like Shaanxi Micot Technology and CVI Pharmaceuticals.

Sahu continues: “Domestic pharma companies in China are warming up to cater to the unmet needs in NAFLD and so we are now seeing companies like Ascletis, Shenzen, Pegbio and CVI Pharma with multiple assets in NAFLD in Phase I and pre-clinical stages. As many of the preclinical molecules are against regular targets like thyroid hormone receptor beta (THR-β), adenosine monophosphate activated protein kinase (AMPK) and farnesoid X activated receptor (FXR) that are currently being investigated in mid-to-late-stage clinical trials by international companies, they are most likely to enter clinical phase.”

In 2021, the Chinese Society of Hepatology adopted the proposed name change for NAFLD to metabolic (dysfunction)-associated fatty liver disease (MAFLD) to encourage funding, research, and public awareness of the disease.

Sahu concludes: “Global gastrointestinal and hepatology medical groups as well as local medical bodies in China have emphasized the importance of early intervention in treating fatty liver diseases. So far, Lipaglyn (saroglitazar), an innovative oral glitazar, is the sole marketed therapy for NAFLD, but approved only in India. There are no approved innovator products for NAFLD in the US or the European Union. Owing to the rising prevalence of NAFLD in China and worldwide, there is a significant market opportunity for Chinese pharmaceutical companies to capitalize on this patient group with significant unmet demand.”